Japan could follow the lead of the European Medicines Agency, which recommended refusing the marketing authorization of the controversial drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (Tokyo).
Japan’s First Committee on New Drugs (NDC) of the Pharmaceutical Affairs and Food Sanitation Council recommended further discussion of the application for the drug. The NDC also requested additional information as it continues its decision-making process.
The Japanese regulators voiced skepticism about clinical data correlating reductions in beta-amyloid with improvement in Alzheimer’s symptoms.
Biogen said it would continue collaborating with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the matter.
Biogen plans on beginning a confirmatory trial for Aduhelm next year, which could conclude in 2026.
Owing to weak demand for the drug in the U.S., Biogen announced that it was slashing the wholesale cost of the drug in half.
Biogen awaits a reimbursement decision from the Center for Medicare and Medicaid Services (CMS) for the drug.
In August, the Institute for Clinical and Economic Review (ICER) announced that an independent appraisal committee unanimously decided the drug had unclear evidence of a “net health benefit.”
ICER recommended that the drug have a wholesale price of $3,000 to $8,400, which is considerably lower than its currently reduced price of $28,200 for a patient with an average weight.
Filed Under: Neurological Disease